Together developed by the Indian Medical Research Council (ICMR) and the standard Central Drugs (CDSCO) control organization, uniform standards apply to in vitro diagnostic (IVDs), used to test 39 critical diseases such as dengue, tuberculosis, malaria, chikungunya, zika virus, NIPAH virus.
“These protocols will bring uniformity to the IVD sector in India and ensure that the test kits used are the highest quality and safety. New instructions will also provide a transparent process for manufacturers, clearly outline specific requirements for sensitivity, specificity and cross reactivity testing,” one of the previously cited officials said.
In vitro diagnostics are tests carried out on samples such as blood or tissue taken from the human body to detect the disease.
The framework indicates the beginning of a uniform national approach to the evaluation of diagnostic products and sets a clear minimum standards and criteria for admission for different markers of critical diseases. The decision comes at a time when the Indian diagnostic industry has spread rapidly after Covid and reached the market size of $ 1.72 billion (FY23) in the fiscal year.
Questions sent to the Ministry of Health remained unanswered until the press.
New rules and assurance of patients
According to the new rules, all diagnostic sets must meet minimal Prague for diagnostic accuracy. For example, the dengue set will now be required to show at least 80% sensitivity and 95% specificity. Sensitivity is a measure of how well the test can properly identify people who have a disease. The sensitivity of 80% suggests that out of 100 people who have a particular disease, the test correctly identifies 80 of them. Similarly, specificity measures exactly how the test correctly identifies those who do not have this disease.
Until now, companies have often relied on their own methods or imported protocols and sets in the absence of standardized test panels, which led to irregularities. The aim of the new framework is to ensure that the set of each manufacturer guarantees the accuracy and reliability of patients across the ground.
“We did not receive the announcements on Friday evening, so my team in J Mitra & Co. And I and I are still going through finer details. It will require another time, effort and costs – whether recturing people to retract people, that it is a meaningful step or documentation,” said Jatin Mahajan, CEO. Standards. While the cost increases, we have committed to absorbing most of them through efficiency and local source, so patients are not affected for me.
Impact on industry and public health
The new framework is a game converter for the Indian diagnostic industry, experts said.
Dr. Rajiv Bahl, ICMR CEO, said in communication that this initiative was caused by a postpandemic expansion of industry. He expressed confidence that new protocols not only improve the quality of IVD in India, but also seize domestic manufacturers to successfully compete for a global license.
“This milestone cooperation is a significant step because it is the first such initiative around the world where the national regulatory body and the National Research Institute have been working together to create standardized protocols for evaluation for high -risk illnesses,” Bahl said.
“The Government of IVD quality is aimed at ensuring precise diagnoses and effective patient care in accordance with the national vision of provision of available, affordable and quality health care for all,” the second official said.
This is a major development for public health in India. Dr. Mahadev Swamy B, consultant in interventional cardiology at Sparsh Hospital in Bengalur, said that inaccurate test results can lead to delayed treatment, patient stress and unnecessary medical intervention.
“Both situations may affect patient safety, increase expenses and also disrupt confidence. Unreliable diagnosis weakens disease control programs and also endanger public health results,” he said. If the test results are not compared to the patient’s symptoms, a repeated or confirming test is often recommended, especially for conditions such as dengue or tuberculosis to ensure accuracy and prevent inappropriate or delayed treatment, Dr. Swamy B.
Prices and outlook
New instructions are expected to improve public health results by guaranteeing IVD quality, which in turn supports the national vision of providing “accessible, affordable and quality health care for all”.
Dr. Sunita Kapoor, director and laboratory leading to the X-Ray & Scan Clinic in Delhi-NCR, said any increase in test prices will depend on whether the sets of sets increase the cost of awarding public procurement.
She added that laboratories with quality knowledge could absorb a minor price increase to prevent patients. “This new environment will require domestic and international manufacturers to ensure that their products are in line with new standards and bring” best for shelves “.
ICMR confirmed that this is a continued effort, with plans to extend the scope to cover other diseases and diagnostic formats in the future.
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